Good Day BIO: FDA Commissioner on Accelerated Approval, food, and more

FDA Commissioner Dr. Robert M. Califf joined the final day of BIO International Convention—here’s what he said about Accelerated Approval, misinformation, and the things the agency does other than drugs. (776 words, 3 minutes, 52 seconds)

FDA Commissioner on Accelerated Approval, misinformation, and more

FDA Commissioner Dr. Robert M. Califf joined the 2022 BIO International Convention for a fireside chat, in which he discussed his view on Accelerated Approval, what he considers the leading cause of death in America, and the legacy he hopes to leave behind.

On Accelerated Approval 

“I’m a big fan of Accelerated Approval,”he told BIO President and CEO Dr. Michelle McMurry-Heath. 

He explained that we need to think about it like a relay race: “FDA shouldn’t stop trying to be the fastest team and the most efficient team on the first lap.” Still, we shouldn’t “just drop the baton at the end of the first lap and hope [Centers for Medicare and Medicaid Services] can find the baton and get going.” 

 “Making sure those confirmatory studies get done is really the critical thing,” he said, responding to Dr. McMurry-Heath’s question about Accelerated Approval in the FDA user fee negotiations. “The public is watching closely.” 

On Misinformation & Life Expectancy 

“Misinformation is the leading cause of death in the United States today,” he said, noting that almost all COVID deaths now are preventable, if patients are up-to-date on vaccines. 

He related it to the dismal life expectancy in the U.S., which is “not because of some mysterious problem but because of chronic common disease,” including heart disease, diabetes, and mental health. “For most of these things, we do have effective treatments already—they just need to be used better.” 

On His Legacy 

When asked what legacy he hopes to leave at FDA, after serving his second term, Dr. Califf responded: “leaving the FDA in a better position than it was in to optimize public health.” 

He also discussed his views on evidence-generation, the role of technology in real-world data, and more—read the recap on Bio.News.

More Health Care News: 

Bio.News: Panelists praise FDA’s cooperation on PDUFA
“Improvements proposed to the next iteration of the Prescription Drug User Fee Act (PDUFA) include an opportunity for developers of candidate drugs to hold more meetings with the FDA, an increase in staff that will build expertise at the FDA, a new rare disease program, and provisions to support diversity in clinical trials, according to a panel moderated by Khushboo Sharma, Chief of Staff and Senior Vice President at BIO. Potential problems with PDUFA VII include changes to the FDA’s Accelerated Approval pathway.” 

Bio.News: Panel decries lack of attention for antimicrobial resistance
“We need to bring the passion that our community now has to tackle pandemics and bring it to AMR,” said Colonel (Ret.) Matthew Hepburn of DARPA. “I’m cautiously optimistic.”

But, hey—FDA’s more than drugs

Speaking at the BIO International Convention, FDA Commissioner Dr. Robert M. Califf also noted the agency’s important work for food and animals—and why this needs more resources, too.

FDA’s medical products side “is working pretty darn well,”FDA Commissioner Califf told BIO President and CEO Dr. Michelle McMurry-Heath. 

But the food side is “chronically underfunded”—and needs a “shot in the arm like 21st Century Cures,” which is “designed to accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently,” as the FDA explains. 

“The center for veterinary medicine is the most under-appreciated part of FDA,” he added, which impacts food, animal health, and pet food.

With the right investment, there’s a lot that can be done—especially around “technology-driven foods” (a.k.a. biotech) and nutrition in the era of big data.

If you didn’t already, read the whole thing on Bio.News.

More Agriculture and Environment News: 

Electrek: Can food waste be turned into green hydrogen to produce electricity?
“Researchers say that this new process, which uses food waste to biologically produce hydrogen, can be used as a clean energy source for producing electricity, as well as for chemical and industrial processes or as a transportation fuel.” 

The Washington Post: 49 million people face famine as Ukraine war, climate disasters intensify
“As of last week, about 750,000 people around the world were facing a food security ‘catastrophe’ — at which ‘starvation, death, destitution and extremely critical acute malnutrition levels are evident’ — according to the Food and Agriculture Organization.”

President Biden’s Friday: Hosting Major Economies Forum on Energy and Climate, where he’s expected to reaffirm U.S. leadership to galvanize actions that strengthen energy security, enhance global food security, and tackle the climate crisis. 

What’s Happening on Capitol Hill: ICYMI, several Biden administration health officials appeared before the Senate Health, Education, Labor, and Pensions (HELP) Committee on Thursday—here’s a recap in POLITICO.